Diagnostic CDMO Services

Biopharma Group has the capability to offer a range of R&D to production CDMO services to a global diagnostics customer-base – from reconstitution to friability, our CDMO and contract freeze drying services for the diagnostics sector aim to provide clear insights on the robustness, solubility, and integrity of many formulations.

Using MDSC and Karl Fisher titration techniques, Biopharma Group is equipped to perform deep, investigative research into the liquid and dried formulations that you may have developed independently or alongside us – to provide expert insight into quality control, state, and the recommended processes for your product.

With a comprehensive range of advanced analytical tools, our contract freeze drying facilities can provide invaluable support for critical phases of product development - these include:

• Lyostat freeze drying microscopy (FDM): Freeze drying microscopy is utilitised to enable precise identification and recording of critical events and collapse temperatures.
• Lyotherm frozen state analyser: This combines electrical and thermal techniques – allowing two analyses to be conducted simultaneously to conduct the analysis and measurement of glass transition, eutectic, and melting temperatures before freeze-drying. The integration of modulated differential scanning calorimetry (MDSC) further enhances the understanding of thermal properties throughout the process. 
• MicroPress post-lyo process assessments: As a mechanical propoerty analysis, this instrumentation is used during post-lyo analysis to determine the quantitative mechanical properties of lyocakes and lyobeads using a linear actuator to determine strength and robustness for safe handling and shipment.
• Karl Fischer Titration: We employ this to ensure quality control by measuring residual moisture content post freeze-drying, while Dynamic Vapour Sorption (DVS) offers insights into a material's moisture sorption properties.

Biopharma Group also has the ability to produce lyobeads - freeze-dried spheres of customisable material. Lyobeads are created through snap freezing and feature larger surface areas compared to standard lyocakes - accelerating the reconstitution process, further highlighting Biopharma Group’s commitment to enhancing the efficiency and effectiveness of diagnostic and pharmaceutical R&D.

Download a copy of our "Diagnostics Services & Solutions: From Research & Development to Manufacture" Overview Brochure

Our Diagnostics Production Credentials:

• 15 in-house freeze dryers from benchtop, to Pilot R&D to commercial scale, we have capacity for one-off batch runs, through to on-going production
• Greater than 10²m of freeze drying shelf space
• Capacity to run batches from 1 plate to 150 plates in a single machine – in 96 well plate or tube format
• Secure worldwide shipping from -80°c to ambient temperatures
• More than 2.5 million Covid tests produced per month during the peak Covid-19 period of 2020-2022
• Leading manufacturer of diagnostics supplied to the NHS during Covid-19 pandemic
• Biopharma Group was instrumental in the evolution of using lyobead technology for fast-turnaround, cost efficient, precise dosing and easy to reconstitute.